<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200829048554N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-04</date_registration>
      <primary_sponsor>The University of Shahid Beheshti</primary_sponsor>
      <public_title>The Effect of Resistance Training to Improve Bone Mineral Density</public_title>
      <acronym>BMD</acronym>
      <scientific_title>Comparison of the Effect of High Intensity and Low Intensity Resistance Traning on Bone Indexes in Wowen with steopenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50802</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Sample Size of this Study is 45 People Available who Should be Divided into three Groups of 15 People In this Study  Before Starting and Before Seeing the Subjects the Researcher Determines by Drawing LotsWhich Group Each Person Should be in In Fact The Researcher  Makes a Random Allocation, Blinding description: Given that The Subjects are Divided into Three Groups but all Subjects Think that There is One Group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Decreased Bone Density in Postmenopausal Women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Due to Individual Differences and a Maximum Repetition, ie the Maximum Weight that a Person can Move for one Time, Resistance Training with High Intensity Dumbbells 70 to 85% A Maximum Repetition and 6 to 10 Repetitions are Performed on the Extensor Muscles of the Trunk and the Muscles of the front and Back of the Leg for 4 Months. It Should be Noted that the Exercises Lasted for 20 Minutes in the First Month and 60 Minutes. Intervention 2: Intervention Group2: Due to Individual Differences, Resistance Exercises with Low Intensity of 50 to 65 in bad one Maximal Repetition and 10 to 16 Repetitions on Extensor Trunk and Front and Back Muscles bad Exercises are Performed for 4 Months. Intervention 3: Control Group: In all Three Groups Medication Including Calcium and Vitamin D is Started Participants in all three Groups Follow their Previous Diet, and in the Control Group Only Medication Without Exercise Will be Applied.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no More Information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Eslamipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.17, Alliy 4, Madani Ave</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719787413</zip>
        <telephone>+98 25 3663 3665</telephone>
        <email>f.eslamipor76@gmail.com</email>
        <affiliation>The University of Shahid Beheshti</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Eslamipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.17, Alliy 4, Madani Ave</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719787413</zip>
        <telephone>+98 25 3663 3665</telephone>
        <email>f.eslamipor76@gmail.com</email>
        <affiliation>The University of Shahid Beheshti</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age Range 50 to 60 Years
Women with Postmenopausal Osteopenia to be Approved by a Specialist
Weight in the Normal Range and With a Body Mass Index Between 18 and 25 According to the Criteria of the World Health Organization</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of Any Fractures or Surgery on the Lower Limbs and Spine
Taking any Hormonal Medication During Treatment that Affects Bone Tissue Metabolism
History of Hormone Therapy and Regular Exercise During the Last 6 Months and During the Study Period
People With Joint Diseases Such as Osteoarthritis and Osteoarthritis of the Lower Extremities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M81.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post menopausal osteoporosis without fracture</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Due to Individual Differences and a Maximum Repetition, ie the Maximum Weight that a Person can Move for one Time, Resistance Training with High Intensity Dumbbells 70 to 85% A Maximum Repetition and 6 to 10 Repetitions are Performed on the Extensor Muscles of the Trunk and the Muscles of the front and Back of the Leg for 4 Months. It Should be Noted that the Exercises Lasted for 20 Minutes in the First Month and 60 Minutes</i_keyword>
      <i_keyword>Intervention Group2: Due to Individual Differences, Resistance Exercises with Low Intensity of 50 to 65 in bad one Maximal Repetition and 10 to 16 Repetitions on Extensor Trunk and Front and Back Muscles bad Exercises are Performed for 4 Months</i_keyword>
      <i_keyword>Control Group: In all Three Groups Medication Including Calcium and Vitamin D is Started Participants in all three Groups Follow their Previous Diet, and in the Control Group Only Medication Without Exercise Will be Applied</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>In this Study, the Effect of Exercise on People with Osteopenia that Improves their Bone Density. Timepoint: After the Bone Density Test they are Trained for 4 Months and do the Test Again. Method of measurement: Dual Energy X-ray Absorptiometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The University of Shahid Beheshti</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-20</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Tehran</contact_name>
        <contact_address>Shahid Beheshti University, Daneshejo blvd, Shahid Shahriari Sq, Yaman Ave, Shahid Chamran Hwy Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
